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Senior Director, Clinical Supply Chain

Lexington, MA

About Voyager Therapeutics

Voyager Therapeutics, Inc. (Nasdaq: VYGR) is a biotechnology company dedicated to leveraging the power of human genetics to modify the course of – and ultimately cure – neurological diseases. Our pipeline includes programs for Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and multiple other diseases of the central nervous system. Many of our programs are derived from our TRACER™ AAV capsid discovery platform, which we have used to generate novel capsids and identify associated receptors to potentially enable high brain penetration with genetic medicines following intravenous dosing. Some of our programs are wholly owned, and some are advancing with partners including Alexion, AstraZeneca Rare Disease; Novartis Pharma AG; Neurocrine Biosciences, Inc.; and Sangamo Therapeutics, Inc. For more information, visit www.voyagertherapeutics.com.

Voyager Therapeutics® is a registered trademark, and TRACER™ is a trademark, of Voyager Therapeutics, Inc. 

Job Summary:

The Senior Director will be a key leader within the group with a strong background and expertise and will lead all aspects of clinical supply chain which includes supply planning, operations and logistics support. Primary responsibilities will include establishing and managing end-to-end clinical supply for clinical studies in various phases, leading cross functional teams including clinical development/ operations to set up appropriate governance and processes to manage supply.

Position Specific Responsibilities:

  • Responsible for establishing and managing the end-to-end clinical supply for clinical studies/programs in various phases
  • Ensure on-time startup of new studies by having supplies available as required and continuous supply of clinical trial material for assigned studies globally
  • Design and execute packaging and labelling campaigns including label design, translation, and production
  • Review clinical protocols and design appropriate supply chain strategy
  • Support the procurement, labeling and distribution of comparators including placebo
  • Prepare supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams
  • Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies globally
  • Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors
  • Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plan
  • Lead the development of a pharmacy manual and any related updates
  • Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing
  • Manage study closeouts and drug reconciliation at study end
  • Ensure all clinical supply related documents are filed in the eTMF
  • Develop and manage clinical supply budget for assigned studies
  • Oversee Clinical Supply Chain timelines to ensure on-time completion of deliverables

Specialized Knowledge & Skills:

  • Experience with international distribution and logistics for clinical programs, including importing and exporting clinical supplies globally

Requirements:

Educational Requirements:

  • Bachelor’s degree in business operations, supply chain, engineering, or related field
  • Advanced degree in business operations or supply chain is a plus

Experience:

  • 12+ years of relevant supply chain and logistics experience in the biotech/pharmaceutical industry
  • Experience with both small and large pharma is a plus.
  • Experience in protein therapeutics, gene therapy or viral vector space is a plus
  • Demonstrated leadership in managing cross-functional teams and stakeholders for effective communication and alignment

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